Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance

NCT ID: NCT02234440

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2015-12-31

Brief Summary

In this study, consecutive patients with cryptogenic cirrhosis (NASH-related cirrhosis), coming to ILBS (Institute of Liver & Biliary Sciences) OPD (Out patient Department) or getting admitted in the ward will be enrolled on fulfillment of inclusion/exclusion criteria and consent of the patient. These patients will be randomised to either metformin arm or conventional treatment arm. After enrollment these subjects will be monitored every three monthly for total of 12 months or till the primary endpoint is achieved. At the end of the study, outcome will be measured appropriately.

Conditions

NASH Related Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin

Metformin- 500 mg once daily as a starting dose, can be escalated to 2 g/day to control diabetes

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Insulin

Group Type: ACTIVE_COMPARATOR

Insulin

Intervention Type: DRUG

Interventions

Metformin

Intervention Type: DRUG

Insulin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18 years and above

2. Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related cirrhosis}

3. Presence of diabetes mellitus or insulin resistance

Exclusion Criteria

1. Patients with heart failure

2. Patients with acute kidney injury at the time of enrollment

3. Patients with CKD (Chronic Kidney Disease) or with S. Creatinine > 1 mg/dL

4. Patient with active upper GI bleeding- not settled

5. Patient with SIRS/sepsis/shock

6. Patient in ICU (Intensive Care Unit)

7. Pregnancy

8. Patients with hepatocellular carcinoma

9. Patients who are not willing to participate in the study

10. Patients with any form of decompensation at the time of enrollment in the study

11. Patient with large esophageal varices/ patients who are on beta blocker other than those patients with HVPG (Hepatic Venous Pressure Gradient) non responder to betablocker

12. Patient who has already been receiving Metformin prior to enrollment in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Tanmay S Vyas, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS-NASH-Cirrhosis-01

Identifier Type: -

Identifier Source: org_study_id